| CTRI Number |
CTRI/2026/02/104352 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two laryngoscopes in pregnant patients with high blood pressure undergoing caesarean section under general anaesthesia |
|
Scientific Title of Study
|
COMPARISON OF INTUBATING CONDITIONS WITH KINGVISION VIDEOLARYNGOSCOPE AND CONVENTIONAL LARYNGOSCOPE IN PATIENTS WITH PRE-ECLAMPSIA REQUIRING GENERAL ANAESTHESIA FOR CAESAREAN SECTION |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College Of Medical Sciences |
| Address |
UCMS and GTBH second floor hospital block
near main icu East DELHI 110095 India |
| Phone |
9625900739 |
| Fax |
|
| Email |
rashmichabra@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College Of Medical Sciences |
| Address |
UCMS and GTBH second floor hospital block near main icu East DELHI 110095 India |
| Phone |
9625900739 |
| Fax |
|
| Email |
Rashmichabra@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr. Rashmi Salhotra |
| Designation |
Professor |
| Affiliation |
University College Of Medical Sciences |
| Address |
UCMS and GTBH second floor, hospital block
near main icu East DELHI 110095 India |
| Phone |
9625900739 |
| Fax |
|
| Email |
Rashmichabra@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
University College of Medical Sciences |
| Address |
UCMS/GTBH Dilshad Garden
Shahdara- Delhi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Rashmi Salhotra |
UCMS/GTBH |
Deaprtment of Anaesthesia and Critical Care. Second Floor. Near main icu East DELHI |
9625900739
Rashmichabra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Guru Teg Bahadur Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
King Vision Video Laryngoscope |
A channeled KVL will be used for intubation. A tracheal tube with an internal diameter of 7.0 mm will be mounted on the KVL. |
| Comparator Agent |
Macintosh Laryngoscope |
Macintosh Laryngoscope will be used for intubation. A tracheal tube with an internal diameter of 7.0 mm will be used |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Twenty two consenting pregnant patients in each group with pre-eclampsia as diagnosed by ACOG guidelines of age more than 18 years and ASA physical status 2 and 3 scheduled for caesarean section requiring GA with tracheal intubation will be enrolled. |
|
| ExclusionCriteria |
| Details |
Patient refusal patients requiring awake intubation and eclampsia |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Proportion of patients having Cormack and Lehane glottic view grade one |
Proportion of patients having Cormack and Lehane glottic view grade one at time of laryngoscopy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Laryngoscopy time
Tube insertion time
Time to successful intubation
Intubation difficulty Score (IDS)
First attempt success rate
Percentage of difficult intubation
|
All parameters at the time points of laryngoscopy & intubation |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
04/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Rationale Videolaryngoscopes are being widely used as first choice for tracheal intubation. Anatomic and physiologic changes during pregnancy place the parturient at increased risk for airway management problems. Obstetric patients with pre-eclampsia have already anticipated difficult airway. The predictors of difficult direct laryngoscopy are not applicable to predict a difficult videolaryngoscopy. Title To compare intubating conditions with Kingvision videolaryngoscope and conventional laryngoscope in pre-eclampsia patients requiring general anaesthesia for caesarean section. Objectives To evaluate and compare the difficulty encountered by anaesthesiologists by Kingvision videolaryngoscopy vs conventional laryngoscopy in terms of Cormack Lehane grade laryngoscopy time tube insertion time time for successful intubation intubation difficulty score percentage of difficult intubation and success rate of intubation in the first attempt. Methods This prospective, randomised study will be conducted in the Department of Anaesthesiology and Critical Care, UCMS and GTBH from March 2026 to December 2026. Pre-eclampsia patients of age more than18 years and ASA physical status 2 3 with Mallampati score 2 3 scheduled for caesarean section requiring General Anaesthesia with Tracheal Intubation will be enrolled. Patients requiring awake intubation and refusing to participate will be excluded. Patients will be randomly allocated to one of the two groups. Standard anaesthesia technique will be followed and intubation will be performed using a Kingvision videolaryngoscope or conventional Macintosh laryngoscope depending on the group allocated. Sample size and Statistical analysis According to a previous study it has been reported that 79.6 per cent patient in whom intubation was done using Kingvision videolaryngoscope had CL grade 1 views and 33.8 per cent patient had CL grade 1 views in Macintosh laryngoscope group in obstetric patients. To estimate the same difference using two-tailed test at alpha equal to 5 per cent and power 80 per cent minimum sample size of 22 in each group is required.
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